As a preview to some of the issues that will be discussed in our upcoming 9th Annual Pharmaceutical Law, Reform & Regulation Conference, we spoke with Samantha Robertson, Executive Director, Evidence, Advice and Governance Branch, NHMRC to discuss the Good Practice Process for site assessment and authorisation of clinical trials.
1. Can you tell us about your role within the NHMRC?
I am the Executive Director of Evidence, Advice and Governance for the NHMRC. Under the National Health and Medical Research Act, I assist the NHMRC CEO to deliver on her statutory responsibilities; to develop and approve ethical, clinical and public health guidelines, and provide advice to the community on health issues of significance. Some interesting projects I have been involved with are the review and release of the 2013 Australian Dietary Guidelines as well as the publication of a guide for health practitioners to assist them in managing individual exposure to lead. I am also responsible for strategic planning, corporate governance and of most relevance to this audience, I am responsible for the NHMRC work on streamlining clinical trial ethics and governance processes.
2. What role does the NHMRC play in clinical trials in Australia?
In conjunction with the Department of Industry, Innovation and Science, the Department of Health and all Australian jurisdictions, NHMRC has delivered a number of reforms that will assist researchers recruit participants and improve consistency in the oversight and conduct of clinical trials. One of these achievements is the creation of the website www.AustralianClinicalTrials.gov.au. This website enables potential clinical trials participants to find and register in suitable clinical trials and is currently being enhanced to advertise the capacity and capability of clinical trials sites which will be of significant benefit to the public and industry. Other initiatives are the trialling of the Good Practice Process for streamlined site assessment and authorisation of clinical trials, which has shown promising results; development of contemporary safety monitoring and reporting guidance, which will clarify the roles of stakeholders in this process, and which has been endorsed by the TGA; and the establishment of national scientific review committees which will be able to provide advice on clinical trials involving medical devices and on research involving complex genetics.
3. Could you tell us a bit about the Good Practice Process for site assessment and authorisation of clinical trials that is currently being piloted?
The Good Practice Process aims to streamline clinical trial site assessment and site authorization. The process was initially piloted at 16 sites around Australia and sought to determine whether by the use of a streamlined research governance system, along with the use of a clinical trials liaison officer as a point of contact between the site and sponsors, could help to reduce the time to clinical trials commencement. Data obtained from the 16 sites has demonstrated that on average, the time taken to commence a clinical trial was reduced by more than 100 days. This is very impressive, although there is certainly the opportunity to reduce timeframes further. However, this will be explored in Phase 2 of the trial.
4. What impact will this new process have on current pharmaceutical testing?
Clearly, if implemented, use of the Process can have a dramatic effect on clinical trial commencement times. However, further improvement in times is also dependent on efforts made by industry as data has shown that some of the time lag is due to those processes also.
It is important to note that the Good Practice Process isn’t focused on pharmaceutical testing itself. Rather the Process is about improving and streamlining authorisations and approvals. Adoption of the Good Practice Process may lead to more clinical trials being conducted in Australia – that’s our hope certainly – but we are also interested in driving improvements to Australia’s healthcare system and the evidence from clinical trials is how we see that occurring. So the Good Practice Process is for academic, comparative-effectiveness trials, surgical trials and behavioural interventions as well as new drug development.
Some of NHMRC’s other work, for example our work to revise Safety Guidance, which I mentioned before, should also assist pharmaceutical companies. Australia is a small market in a global development space and so we have tried to develop a national approach to conducting clinical trials that is consistent with world best practice, while also being appropriate for Australia’s regulatory environment.
5. There’s been a lot of commentary on Australia’s $20billion Medical Research Future Fund. What are the NHMRC’s thoughts on the fund and its potential impact on medical research and development in Australia?
The establishment of the Medical Research Future Fund (MRFF) will, over time, provide substantial additional funding for medical research and medical innovation. Strategic alignment between the funding priorities for the MRFF and those of the NHMRC is essential to ensure the efficient and effective allocation of funds from both sources.
Ms Robertson will focus on how a collaborative cross-sector approach has realised improvements in clinical trial start-up times, at the 9th Annual Pharmaceutical Law, Reform & Regulation Conference. For more information, including our current agenda, please head to our website.